Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:47 AM
Study NCT ID:
NCT07449351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psilocybin Microdosing on Cognition, Mood and Quality of Life
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Effects of Psilocybin Microdosing on Cognition, Mood and Quality of Life: A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences.
Detailed Description:
This study is being conducted to evaluate the effects of 30 days of intermittently microdosed psilocybin in a parallel arm double-blind manner on mood, cognition, subjective well-being and structural/functional MRI compared to placebo, using validated psychological assessments and cognitive tests. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences.
Demonstrating significant results in a population of healthy psychedelic non-users will establish a strong precedent for studying the effects of microdosing psychedelics in patient populations, such as those with treatment-resistant depression. Showing that microdosing minimizes risk of adverse outcomes with psychedelic treatment while maintaining beneficial effects would provide useful information relevant to clinical research in psychedelic-assisted psychotherapy. In addition to investigating claims that microdosing psychedelics may improve cognition and mood, this study also aims to test the hypothesis that these effects including those measurable at a brain level may persist beyond the course of the 30 days of the study. There are few to no studies that assessed the longevity of psychedelic effects on the majority of the above measures, so the proposed study may further establish the longer-term benefits of microdosing. The use of structural and functional magnetic resonance imaging (fMRI) will elucidate the mechanisms by which microdosing may be exerting its effects on mood and cognition. Because this is a relatively understudied area, information gleaned from this study will provide service in informing the field in general.
Demonstrating significant results in a population of healthy psychedelic non-users will establish a strong precedent for studying the effects of microdosing psychedelics in patient populations, such as those with treatment-resistant depression. Showing that microdosing minimizes risk of adverse outcomes with psychedelic treatment while maintaining beneficial effects would provide useful information relevant to clinical research in psychedelic-assisted psychotherapy. In addition to investigating claims that microdosing psychedelics may improve cognition and mood, this study also aims to test the hypothesis that these effects including those measurable at a brain level may persist beyond the course of the 30 days of the study. There are few to no studies that assessed the longevity of psychedelic effects on the majority of the above measures, so the proposed study may further establish the longer-term benefits of microdosing. The use of structural and functional magnetic resonance imaging (fMRI) will elucidate the mechanisms by which microdosing may be exerting its effects on mood and cognition. Because this is a relatively understudied area, information gleaned from this study will provide service in informing the field in general.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: